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Trial Title:
The Prognostic Impact of Tumor Location in Non-Muscle-Invasive Bladder Cancer Patients
NCT ID:
NCT06245759
Condition:
Non-Muscle-Invasive Bladder Cancer
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Other
Intervention name:
This was a retrospective study and no patient intervention was performed
Description:
This was a retrospective study and no patient intervention was performed
Arm group label:
the Chinese Bladder Cancer Alliance CBCC database
Arm group label:
the U.S. National Cancer Center SEER database
Summary:
Based on large sample size studies at home and abroad, the prognosis of patients with
non-muscular invasive bladder cancer in different sites undergoing transurethral bladder
tumor resection was determined, providing important guidance for subsequent clinical
treatment and surgical instrument development.
Detailed description:
Background Most bladder cancers are non-muscle invasive bladder cancer (NMIBC), and
transurethral resection of bladder tumors (TURBT) is the standard treatment. However,
postoperative recurrence poses a challenge, and the influence of bladder tumor location
on prognosis is unclear. This study aims to investigate how tumor location affects NMIBC
patients' prognosis undergoing TURBT, and seeks optimal surgical approaches.
Methods Conducted a multicenter study, including Chinese NMIBC data from 15 hospitals
(1996-2019) and SEER 17 registries (2000-2020). Analyzed patients initially diagnosed
with NMIBC undergoing TURBT or partial cystectomy, excluding cases with lost follow-up or
missing data. Studied overall survival (OS), disease-specific survival (DSS), and
recurrence-free survival (RFS). Employed Kaplan-Meier, Cox regression, and propensity
score matching to explore the association between tumor location and prognosis.
Stratified populations were analyzed to minimize bias.
Findings This study, involving 118,477 NMIBC patients, highlighted tumor location as a
crucial factor impacting post-TURBT prognosis. Anterior wall and dome tumors
independently predicted adverse outcomes in both cohorts. For anterior wall tumors,
Chinese cohort showed OS HR 4.35, p < 0.0001; RFS HR 2.21, p < 0.0001; SEER OS HR 1.10, p
= 0.0001; DSS HR 1.13, p = 0.0183. Dome tumors displayed similar trends (Chinese NMIBC
cohort OS HR 7.91, p < 0.0001; RFS HR 2.12, p < 0.0001; SEER OS HR 1.05, p = 0.0087; DSS
HR 1.14, p = 0.0006). Partial cystectomy significantly improved dome tumor survival
compared to standard TURBT (p < 0.01).
Interpretation This study reveal that NMIBC tumor location significantly influences TURBT
treatment outcomes. Specifically, tumors in the anterior wall and bladder dome have worse
post-TURBT prognosis. Compared to TURBT, partial cystectomy improves prognosis for
bladder dome tumors. This study guides personalized treatment and prognosis management
for NMIBC patients.
Criteria for eligibility:
Study pop:
This study utilized the Chinese NMIBC cohort as well as the SEER 17 registries cohort for
its investigation. The Chinese NMIBC cohort contains data of patients between January
1996 and December 2019, at 14 institutions. SEER*Stat software (version 8.4.1.1) was used
for collecting 17 registries cohort data on patients diagnosed with NMIBC between 2000
and 2020.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Initially diagnosed with non-muscular invasive bladder cancer (NMIBC) who underwent
TURBT or partial cystectomy.
2. The follow-up data of the patients were complete.
3. The tumor location information were complete.
Exclusion Criteria:
1. Patients with unknown survival time or missing tumor location information were
excluded.
2. Exclude patients with missing pathological results.
3. Exclude patients who have had TURBT before.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ke Chen
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Recruiting
Contact:
Last name:
Lilong Liu
Phone:
+8618186431204
Email:
ddluis1204@163.com
Start date:
August 31, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Huazhong University of Science and Technology
Agency class:
Other
Source:
Huazhong University of Science and Technology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06245759
